MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION SPECTRA WAVEWRITER; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-1160

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Intermittent Energy Output (4025)

Patient Problems Fall (1848); Injury (2348)

Event Date 06/26/2018

Event Type  Injury  

Event Description

A report was received that the patients stimulator was turning off and on randomly when on a higher setting causing her leg to collapse, lost her balance and fell on the concrete.It was noted that the patient broke her humerus near the shoulder.

Manufacturer Narrative

Additional information was received that the patient was reprogrammed and was getting good relief.Database analysis revealed no anomalies.No further course of action will be taken at this time.

Event Description

A report was received that the patients stimulator was turning off and on randomly when on a higher setting causing her leg to collapse, lost her balance and fell on the concrete.It was noted that the patient broke her humerus near the shoulder.

• Brand Name: SPECTRA WAVEWRITER
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7754337
• MDR Text Key: 116153348
• Report Number: 3006630150-2018-60499
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729951254
• UDI-Public: 08714729951254
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/21/2020
• Device Model Number: SC-1160
• Device Catalogue Number: SC-1160
• Device Lot Number: 331141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR